prospective, multicenter, investigation of the adagio cryoablation system in subjects with atrial flutter

Conditions: Atrial Flutter

Summary: the objective of the study is to demonstrate the safety and feasibility of the adagio system in subjects with atrial flutter.


Eligibility criteria:
inclusion criteria: * two symptomatic episodes of typical afl (or chronic atrial flutter) during the one-year period prior to enrollment. this may include typical afl occurring while receiving anti-arrhythmic drug (aad) therapy for non-afl tachyarrhythmia, including atrial fibrillation (af). * at least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ecg) within 6 months prior to enrollment. * subject has been diagnosed with symptomatic afl * subject is at least 18 and ≤75 years of age. * subject is able and willing to give informed consent exclusion criteria: * intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a tee (trans-esophageal echocardiogram) and/or ct did not conclusively rule out thrombus * subject developed persistent af at least once in history (electrical or pharmacological cardioversion after 48h or episode duration \>7 days). subject had any previous left atrial ablation. * subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case of an isolated coronary bypass surgery performed more than three months prior to the procedure. * subject has permanent pacemaker or defibrillator implant. * subject has 2° type ii, 3° degree atrioventricular (av) block or left/right bundle branch block pattern * subject has unstable angina pectoris. * subject has history of previous myocardial infarction (mi) or percutaneous intervention during the last three months or planned in the next 3 months. subject has symptomatic carotid stenosis. * subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease. * subject has any contraindication for oral anticoagulation. * subject has any history of previous transient ischemic attack (tia) or stroke. * subject has known intra-cardiac thrombus formation. * subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed). * subject has evidence of congestive heart failure (nyha class ii, iii or iv) in sinus rhythm. * subject has hypertrophic cardiomyopathy. * subject has abnormal long or short qt interval, signs of brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia. * subject has sarcoidosis. * subject has myxoma. * subject has thrombocytosis (platelet count \> 600,000 / μl) or thrombocytopenia (platelet count \<100,000 / μl). * subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism. * subject has renal dysfunction with glomerular filtration rate \< 60 ml/min/1.72m2. * subject has a reversible causes for af like alcoholism. * subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception \[oral contraception or intra-uterine device\] (who must have a negative pregnancy test within 1 week of randomization) or sterile woman can be enrolled. * subject is a breastfeeding woman. * subject has an active systemic infection. * subject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer requiring ongoing in-hospital treatment, severe bleeding in history or a suspected pro-coagulant state. * legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up. * subject has a life expectancy of ≤ 1 year. * subject is participating in any other clinical study